On 2nd November 2017, the Food and Drug Administration (FDA) granted breakthrough therapy designation for GlaxoSmithKline’s B cell maturation antigen (BCMA)-directed antibody-drug conjugate, GSK2857916. This novel drug will now be further developed to treat patients with Relapsed and Refractory Multiple Myeloma (RRMM) who have received at least three prior therapies that include an anti-CD38 antibody, an immunomodulatory agent and a proteasome inhibitor.
This conjugate comprises a protease-resistant maleimidocaproyl linker to combine monomethyl auristatin-F – a microtubule-disrupting agent – with a human IgG1 anti-BCMA. BCMA has been identified as a key target in MM, as it is highly expressed on plasma cells.
Such breakthrough designation status aims to speed up development by allowing the rapid design and implementation of further clinical trials. This decision was based on data from a Phase I dose-escalation and expansion study treating RRMM patients that were not pre-screened for BCMA expression, published in Blood in 2016. Preliminary results from the BMA117159 study (part 2 of this initial trial) will be presented in an oral presentation on 11-Dec-2017 at the forthcoming 2017 ASH Annual Meeting. PRIME therapy designation was granted by the European Medicines Agency (EMA) in October this year.